Chronic Obstructive Pulmonary DiseasePhase 3NCT01056081
Inspiratory Muscle Training in Chronic Obstructive Pulmonary Disease
A Phase 3 study testing Inspiratory muscle training in people with Chronic Obstructive Pulmonary Disease, run by Faculdade Evangelica do Parana.
Trial summary
Uncertainty persists regarding the usefulness of incorporating inspiratory muscle training (IMT) in pulmonary rehabilitation programs for patients with chronic obstructive pulmonary disease. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Inspiratory muscle training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- Apr 2006to Dec 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with a clinical and spirometric diagnosis of moderate to severe COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD)
- In a stable condition (without exacerbations or infections for at least a month)
- Had to be former smokers (> 6 months without smoking)
- subjects referred by a physician to the Pulmonary Rehabilitation Program
Who cannot join
- Subjects with a known history of asthma, or severe and/or unstable heart disease or any other pathological condition that could impair their physical activities
About this study
Official title: Inspiratory Muscle Training for Patients With Chronic Obstructive Pulmonary Disease Undergoing a Pulmonary Rehabilitation Program
Uncertainty persists regarding the usefulness of incorporating inspiratory muscle training (IMT) in pulmonary rehabilitation programs for patients with chronic obstructive pulmonary disease. In this study the investigators investigate whether IMT associated with exercise training would be better than exercise training alone, with regard to exercise capacity, inspiratory muscle strength and dyspnea.
Read the detailed description
Study design: A double-blind parallel controlled trial Setting: outpatient clinic Inclusion criteria: Subjects between 40 and 75 years of age referred by a physician to the Pulmonary Rehabilitation Program, with a clinical and spirometric diagnosis of moderate to severe COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD).
Outcome measurements: Inspiratory muscle strength (using maximal inspiratory pressure, MIP), exercise capacity (using six-minute walk test) and dyspnea were measured.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Inspiratory muscle training
- Keywords
- COPD, inspiratory muscles, diaphragm
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle trainingOther
Also called IMT
The training was performed using a threshold inspiratory muscle trainer (Respironics HealthScan, Inc, Cedar Grove, New York, USA).
The patients performed the IMT training in a seated position, with the upper limbs supported. The total duration of the respiratory training was 30 minutes, with sequences of three minutes of training followed by pauses of two minutes. The initial load was equivalent to 30% of the individual's MIP. This load was progressively increased over the first four weeks, according to the patients' tolerance, to reach 60% of the MIP. This level was then maintained until the end of the training.
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory muscle training | Experimental | The training was performed using a threshold inspiratory muscle trainer (Respironics HealthScan, Inc, Cedar Grove, New York, USA).
The patients performed the IMT training in a seated position, with the upper limbs supported. The total duration of the respiratory training was 30 minutes, with sequences of three minutes of training followed by pauses of two minutes. The initial load was equivalent to 30% of the individual's MIP. This load was progressively increased over the first four weeks, according to the patients' tolerance, to reach 60% of the MIP. This level was then maintained until the end of the training. Receives: Other: Inspiratory muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory muscle strength
Measured: 8 weeks
Secondary outcomes (2)
Exercise capacity
Measured: 8 weeks
Dyspnea
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
- Study startApr 2006
- Primary completionApr 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculdade Evangelica do Parana
- Sponsor type
- University, hospital or other
- Investigators
- Silvia R Valderramas, PhD, Study chair, Evangelical Faculty of Paraná
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01056081
- Sponsor's protocol ID
- FEPAR 1768
- Status last verified
- Mar 2006
- First submitted
- 22 Jan 2010
- Last updated
- 26 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inspiratory Muscle Training for Patients With Chronic Obstructive Pulmonary Disease Undergoing a Pulmonary Rehabilitation Program
- ClinicalTrials.gov ID
- NCT01056081
- Acronym / sponsor ID
- FEPAR 1768
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, inspiratory muscles, diaphragm
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Faculdade Evangelica do ParanaUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 26 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Uncertainty persists regarding the usefulness of incorporating inspiratory muscle training (IMT) in pulmonary rehabilitation programs for patients with chronic obstructive pulmonary disease. In this study the investigators investigate whether IMT associated with exercise training would be better than exercise training alone, with regard to exercise capacity, inspiratory muscle strength and dyspnea.
Detailed description
Study design: A double-blind parallel controlled trial Setting: outpatient clinic Inclusion criteria: Subjects between 40 and 75 years of age referred by a physician to the Pulmonary Rehabilitation Program, with a clinical and spirometric diagnosis of moderate to severe COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD).
Outcome measurements: Inspiratory muscle strength (using maximal inspiratory pressure, MIP), exercise capacity (using six-minute walk test) and dyspnea were measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inspiratory muscle training | Experimental | Other: Inspiratory muscle trainingThe training was performed using a threshold inspiratory muscle trainer (Respironics HealthScan, Inc, Cedar Grove, New York, USA). The patients performed the IMT training in a seated position, with the upper limbs supported. The total duration of the respiratory training was 30 minutes, with sequences of three minutes of training followed by pauses of two minutes. The initial load was equivalent to 30% of the individual's MIP. This load was progressively increased over the first four weeks, according to the patients' tolerance, to reach 60% of the MIP. This level was then maintained until the end of the training. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with a clinical and spirometric diagnosis of moderate to severe COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD)
- In a stable condition (without exacerbations or infections for at least a month)
- Had to be former smokers (> 6 months without smoking)
- subjects referred by a physician to the Pulmonary Rehabilitation Program
Key exclusion criteria (1 listed)
- Subjects with a known history of asthma, or severe and/or unstable heart disease or any other pathological condition that could impair their physical activities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory muscle trainingAlso: IMTThe training was performed using a threshold inspiratory muscle trainer (Respironics HealthScan, Inc, Cedar Grove, New York, USA). The patients performed the IMT training in a seated position, with the upper limbs supported. The total duration of the respiratory training was 30 minutes, with sequences of three minutes of training followed by pauses of two minutes. The initial load was equivalent to 30% of the individual's MIP. This load was progressively increased over the first four weeks, according to the patients' tolerance, to reach 60% of the MIP. This level was then maintained until the end of the training. | Other | Inspiratory muscle training |
Primary outcome
Inspiratory muscle strength
Time frame: 8 weeks
2 secondary outcomes
Exercise capacity
Time frame: 8 weeks
Dyspnea
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia R Valderramas, PhD study chair
Evangelical Faculty of Paraná
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Inspiratory muscle training in people with Chronic Obstructive Pulmonary Disease, run by Faculdade Evangelica do Parana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inspiratory muscle strength (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2010.